FDA is overruled on emergency pill; critics cry politics

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WASHINGTON - In an unexpected turn of events, the Food and Drug Administration announced yesterday that it was not going to permit the emergency contraception pill, Plan B, to be sold over the counter without any age restriction. The agency’s commissioner said she had planned to lift the age restrictions but was overruled by Health and Human Services Secretary Kathleen Sebelius.

In dueling press statements, the two Obama administration appointees said they came to opposite conclusions about the safety of making Plan B available to girls under age 17.

The public disagreement was highly unusual, as was Sebelius’s decision to pull rank on the FDA. Women’s health groups were livid, seeing political motivations in the move as the president prepares to seek reelection next year.

FDA Commissioner Dr. Margaret Hamburg said “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.’’

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But Sebelius, who has authority over the FDA, said in her statement that “the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately’’ and that she does not believe that the manufacturer’s application to make Plan B available over the counter met that standard. She said the studies submitted “did not contain data for all ages for which this product would be available for use.’’

She directed the FDA to tell the manufacturer, Teva Pharmaceuticals, that the product would remain as is: stocked behind the pharmacist’s counter and available without a prescription only to women aged 17 and over.

A White House official, who was not authorized to speak publicly, said there was no political calculation behind Sebelius’s decision, adding it is a legitimate question to ask whether young girls can fully comprehend the gravity of their situation and understand the label on a pill bottle.

The FDA and the Health and Human Services Department usually work in lock-step on drug approvals, especially on emotionally-charged matters like contraceptives or the abortion drug mifepristone.

“It’s very unusual for this to happen, and I’m unfamiliar with any circumstance in which it has happened,’’ Tevi Troy, former deputy secretary of Health and Human Services in the administration of George W. Bush, said of the Health and Human Services reversal.

Teva said in a statement that the company is “disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion’’ from the FDA. It added that the company would have to review the decision before determining its next steps.

An agency official said Teva has the option to resubmit an application with additional data or may request a hearing with FDA officials if the company still wants to pursue full over-the-counter access for Plan B.

Plan B, which contains a high dose of the female hormone progestin, has mild side effects, including nausea, abdominal pain, and breast tenderness, and needs to be taken within 72 hours of unprotected sex to be most effective at preventing pregnancy. The newer One-Step product contains just one pill, rather than two to be taken 12 hours apart.

That means the one-pill product is easier to use than the older version that was available when an FDA scientific advisory committee voted in 2003 to recommend that Plan B be sold over-the-counter without any age restrictions. In an controversial move, the FDA at that time decided not to follow the advice of its advisory committee, and it was not until 2006 that it became available over the counter.

Critics blamed the 2003 decision on the Bush administration bowing to pressure from conservatives. That controversy led Susan Wood to resign from the FDA as assistant commissioner for women’s health.

“I don’t understand the politics in this,’’ Wood, now an associate professor of health policy at George Washington University, said yesterday. “Why would this administration and this president, which campaigned that it would respect science, even consider not allowing this drug’’ to become more widely available.

“I was frankly stunned and very disappointed,’’ she said. “It’s very reminiscent of when I left the FDA. . . . It’s happening again.’’

It is unclear how much political calculations were involved in the decision by an administration that strongly supports abortion rights, said Robert Blendon, a Harvard School of Public Health professor. “There could be so many things at play here,’’ he said. “They are clearly reaching out’’ to a political center ambivalent on the abortion issue, or those who might support abortion rights but also support limits on those rights, he said. But for those on polar opposites on abortion, “it’s not a vote changer.’’

Women’s health groups were angered by the administration’s decision.

“It almost seems cruel to limit access to emergency contraception to young people since this is a tool to help them prevent pregnancy,’’ said Patricia Quinn, executive director of the Massachusetts Alliance on Teen Pregnancy. “It’s hard to imagine, as with other decisions regarding adolescent sexual health, that politics wasn’t attached to it.’’

In a letter to the FDA, Sebelius pointed out that Teva had not submitted data on 11- and 12-year-olds, who may not know how to use Plan B properly. But two recent studies suggest that young teens a year or two older are just as likely to use Plan B appropriately as college students, according to Dr. Alisa Goldberg, an obstetrician-gynecologist and director of clinical research at Planned Parenthood League of Massachusetts.

“If these young girls do use Plan B the wrong way - whether too long after unprotected sex or even if they haven’t had sex at all - they won’t incur any harm,’’ Goldberg said. “It’s a safer drug than aspirin or Tylenol.’’

Yesterday’s decision, said Dr. Paula Johnson, chief of women’s health at Brigham and Women’s Hospital, means that the product will remain inconvenient even for older women to obtain, because it will stay behind the pharmacy counter and be dispensed only after someone shows a valid ID. “Time is important since the effectiveness of the medication increases the sooner it’s taken after intercourse,’’ she said.

Antiabortion groups cheered Sebelius for going against the FDA. “The availability of Plan B over-the-counter for all ages would have bypassed necessary routine medical care for sexually active girls,’’ said Jeanne Monahan of the Family Research Council. “There is a real danger that Plan B could be given to young women, especially sexually abused minors, under coercion or without their consent.’’